NCT01349998已完成3 期
An Open-Label Study to Evaluate the Safety of Long-Term Administration of Product 33525 in Subjects With Tinea Pedis, Tinea Corporis, or Tinea Cruris
Tinea Pharmaceuticals0 个研究点目标入组 604 人开始时间: 2011年5月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 604
- 主要终点
- Number of Subjects with Adverse Events
研究概览
简要总结
The purpose of this study is to examine the long-term safety of treating recurrent episodes of tinea pedis for 14 days for each recurrence and recurrent episodes of tinea corporis or tinea cruris for 7 days for each recurrence with Product 33525.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Evidence of tinea cruris, tinea pedis, or tinea corporis. Additional criteria listed in protocol
排除标准
- •Pregnancy and allergies. Additional criteria listed in protocol
研究组 & 干预措施
Safety Population
Experimental
干预措施: Product 33525 (Drug)
结局指标
主要结局
Number of Subjects with Adverse Events
时间窗: One Year
To examine the long-term safety of treating tinea pedis, tinea corporis or tinea cruris, treatment-emergent adverse events occurring during the study will be recorded. Adverse events will be summarized by the number of subjects reporting events, system organ class, preferred term, severity, relationship to study drug, and seriousness. Baseline and end of study laboratory assessments will be conducted.
次要结局
- Clinical Cure and Mycological Cure(1 week Post Treatment, 2 weeks Post Treatment, and 3 weeks Post Treatment)
研究者
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